UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007645 |
|---|---|
| Receipt number | R000009001 |
| Scientific Title | Narrow band imaging, Flexible spectral imaging color enhancement versus white light endoscopy to compare adenoma miss rate in colonoscopy with polypectomy : a tri-modal prospective back-to-back study. |
| Date of disclosure of the study information | 2012/04/02 |
| Last modified on | 2013/10/02 10:08:07 |
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Basic information
Public title
Narrow band imaging, Flexible spectral imaging color enhancement versus white light endoscopy to compare adenoma miss rate in colonoscopy with polypectomy
: a tri-modal prospective back-to-back study.
Acronym
NBI,FICE vs WLE study
Scientific Title
Narrow band imaging, Flexible spectral imaging color enhancement versus white light endoscopy to compare adenoma miss rate in colonoscopy with polypectomy
: a tri-modal prospective back-to-back study.
Scientific Title:Acronym
NBI,FICE vs WLE study
Region
| Japan |
Condition
Condition
patients with adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the AMR among NBI,FICE and WLE.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The adenoma miss rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
NBI-FICE group
Interventions/Control_2
FICE-NBI group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)patients with adenoma
Key exclusion criteria
1) patients from hereditary non-polyposis colorectal cancer(HNPCC)
2) history of medical treatment for inflammatory bowel disease(IBD)
3) history of surgical resection for colorectal cancer
4) incomplete colonoscopy due to inadequate bowel preparation
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | YukinagaYoshida |
Organization
The Jikei University Katsushika Medical Center
Division name
Department of Endoscopy
Zip code
Address
6-41-2,Aoto,Katsushika-ku,Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The Jikei University School of Medicine
Division name
Department of endoscopy
Zip code
Address
TEL
03-3603-2111
Homepage URL
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 02 | Day |
Last modified on
| 2013 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009001
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
